Category Archives: Case for Quaity

12Feb/21

FDA Debunks Industry Myths on Electronic Batch Records and Review by Exceptions

Automating Electronic Batch Record review is a key benefit of Modernizing Manufacturing Operations. Yet concerns regarding FDA’s acceptance of Review by Exception (RBE) has prevented many companies from achieving this goal.

In this “Straight from the Source” episode, FDA’s Francisco Vicenty debunks industry myths on Electronic Batch Records and Review by Exception.

12Mar/19

eBook: CSA – A Streamlined Approach to Validation

Computer System Assurance in Support of Manufacturing 4.0

By: Daniel R. Matlis, President

Computer System Validation (CSA) is a streamlined approach to validation that supports Manufacturing 4.0 in the Life-Sciences.   Medical Device Executives believe this new approach will result in a 30% to 50% reduction in time and cost, and will increase and accelerate improvements and innovation.

This eBook includes success stories and first-hand examples by:

Axendia_Validation_P10-copyrightedFrancisco (Cisco) Vicenty, Program Manager – CfQ, US FDA

Jason Spiegler, Sr. Director, Industry Portfolio Development, Siemens PLM

Damien McPhillips, Sr. Quality Manager – Global Software and Digital Health, Boston Scientific

Ray Murphy, Principal Software Quality Engineer, Boston Scientific

April Francis, Director Global IT Quality and Compliance, Medtronic

Frank Melendandri, Sr., Manager, Quality Assurance, Zoll Lifevest

 

This paradigm shift has had an enormous impact on the industry.  Backed by the FDA, a new era of computer system validation is here. According to Cisco Vicenty, CfQ Program Manager at FDA: “All the recommendations that the Non-Product CSV Guidance is highlighting, is within scope of the FDA’s QSRs and is compliant.”
Continue reading